Drugs / Levocabastine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LIVOSTIN 1996-06-10 fda.gov
Approved US (FDA) LIVOSTIN 1993-11-10 fda.gov

Trials 4 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01962467 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 22 trials
Phase 2 NCT01949051 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01957202 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase not applicable1 trial
NCT04002349 Jul → Dec 2019 Beijing Tongren Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT02498509 Comparator May 2015 → Mar 2016 perennial allergic rhinitis Chong Kun Dang Pharmaceutical Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Levocabastine “A Relative Bioavailability Study to Compare the Pharmacokinetics of a Fixed Dose Combination of Fluticasone Furoate and Levocabastine With Levocabastine and Fluticasone Furoate Alone” NCT01962467
3

NCT04002349

NCT01949051

NCT01957202

Known as LEV “The purpose of the study is to determine the relative bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is administered alone and as FF/LEV Fixed...” NCT01962467
Known as LEVO “OBJECTIVES: To test the hypothesis that intranasal levocabastine (LEVO) may provide benefits as a oncedaily treatment in allergic rhinitis (AR), this non-inferiority study...” PMID 26249767 Oct 2015
1

“OBJECTIVE: To compare the effects of intranasal fluticasone furoate (FF)/levocabastine (LEVO) fixed-dose combination (FDC) with each component alone” PMID 25900517 Aug 2015

Known as Levocabastina ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438
Known as Levocabastine HCL ClinicalTrials.gov intervention name — accepted as the source's own label NCT02498509
Known as LEVOCABASTINE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438
Known as Livostin ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438
Known as Livostin direct ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438
Known as Livostine “Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)” NCT04002349
Known as Livostinet “Levocabastine(Livostinet, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) Nasal Spray” NCT04002349
Known as R 50,547 ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438
Action Inhibit “Histamine H1 receptor antagonist” CHEMBL1615438
Modality Small molecule CHEMBL1615438
Route Intranasal Intranasal aqueous 50 mcg microsuspension of levocabastine” NCT01949051
Target HRH1 “Histamine H1 receptor antagonist” CHEMBL1615438